根据皮肤科生活质量指数评分,斯派索利单抗可迅速改善泛发性脓疱型银屑病患者的生活质量:来自 Effisayil 2 试验的数据

Alice B. Gottlieb, B. Strober, Georgios Kokolakis, Joseph F. Merola, Min Zheng, Richard G. Langley, Ming Tang, Patrick Hofmann, C. Thoma, Richard B Warren
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In Effisayil 2 (NCT04399837), high‑dose spesolimab was superior to placebo in GPP flare prevention and numerically reduced the risk of Dermatology Life Quality Index (DLQI) worsening (≥4-point increase in total score from baseline; secondary endpoint), up to Week 48. \nMethods Here, we further analyze the effect of high-dose spesolimab versus placebo on DLQI in Effisayil 2. \nResults Baseline characteristics were generally similar in the high-dose spesolimab (600 mg loading dose then 300 mg every 4 weeks [N=30]) and placebo groups (N=31) in terms of sex, age, length of disease, and historical flare frequency, although the high‑dose spesolimab group had a higher mean±SD DLQI score (11.1±6.9 [missing=1]) versus placebo (7.2±5.6 [missing=0]). 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引用次数: 0

摘要

导言:泛发性脓疱型银屑病(GPP)是一种慢性疾病,可能危及生命,其特点是皮肤广泛脓疱发作。在Effisayil 2(NCT04399837)研究中,大剂量斯派索利单抗在预防GPP复发方面的效果优于安慰剂,并在第48周之前从数字上降低了皮肤科生活质量指数(DLQI)恶化的风险(总分比基线增加≥4分;次要终点)。方法 在此,我们进一步分析了大剂量斯派索利单抗与安慰剂相比对艾菲赛2的DLQI的影响。结果 大剂量斯派索利单抗组(600 毫克负荷剂量,然后每 4 周 300 毫克[N=30])和安慰剂组(N=31)在性别、年龄、病程和历史发作频率方面的基线特征基本相似,但大剂量斯派索利单抗组的 DLQI 平均分(±SD)(11.1±6.9 [缺失=1])高于安慰剂组(7.2±5.6 [缺失=0])。在第4周的探索性分析中,大剂量斯派索利单抗组(N=29)与安慰剂组(N=31)相比(n/N [%]:10/29 [34.5%] [缺失=1] 对 3/31 [9.7%] [缺失=0]),有更多患者在第4周没有GPP复发且DLQI评分改善≥4分;在第48周也是如此(分别为11/29 [37.9%] [缺失=6] 对 8/31 [25.8%] [缺失=0])。此外,与安慰剂相比,接受斯派索利单抗治疗的患者中,有更高比例的患者在第48周之前的所有访视中均未出现GPP复发并达到DLQI评分0或1分(分别为7/29[24.1%]对1/31[3.2%])。结论 除了先前Effisayil 2的数据外,本分析结果表明,与安慰剂相比,接受斯派索利单抗(包括大剂量)治疗的患者的DLQI评分迅速得到改善,而且这种改善一直持续到第48周。
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Spesolimab Rapidly Improves Quality of Life in Patients with Generalized Pustular Psoriasis, as per Dermatology Life Quality Index Scores: Data from the Effisayil 2 Trial
Introduction Generalized pustular psoriasis (GPP) is a chronic and potentially life-threatening disease characterized by flares of widespread skin pustulation. In Effisayil 2 (NCT04399837), high‑dose spesolimab was superior to placebo in GPP flare prevention and numerically reduced the risk of Dermatology Life Quality Index (DLQI) worsening (≥4-point increase in total score from baseline; secondary endpoint), up to Week 48. Methods Here, we further analyze the effect of high-dose spesolimab versus placebo on DLQI in Effisayil 2. Results Baseline characteristics were generally similar in the high-dose spesolimab (600 mg loading dose then 300 mg every 4 weeks [N=30]) and placebo groups (N=31) in terms of sex, age, length of disease, and historical flare frequency, although the high‑dose spesolimab group had a higher mean±SD DLQI score (11.1±6.9 [missing=1]) versus placebo (7.2±5.6 [missing=0]). At Week 4 in exploratory analysis, more patients in the high-dose spesolimab group (N=29) had no GPP flare and ≥4-point improvement in their DLQI score versus placebo (N=31) (n/N [%]: 10/29 [34.5%] [missing=1] versus 3/31 [9.7%] [missing=0]) at Week 4; this was also seen at Week 48 (11/29 [37.9%] [missing=6] versus 8/31 [25.8%] [missing=0], respectively). Furthermore, a higher proportion of patients treated with spesolimab had no GPP flare and reached a DLQI score of 0 or 1 at all visits up to Week 48 versus placebo (7/29 [24.1%] versus 1/31 [3.2%], respectively). Conclusion Adding to previous data from Effisayil 2, this analysis demonstrates that patients treated with spesolimab (including high-dose) rapidly gained improvements in DLQI scores versus placebo, which were sustained through to Week 48.
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